Rotavirus Vaccine: February 2007 Archives

Merck Updates Prescribing Information For Rotateq®

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rotateqMerck & Co., Inc. today updated the prescribing information for ROTATEQ® (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program.

A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.

FDA: Rotavirus Vaccine May Harm Infants

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vaccination and profitsBy ANDREW BRIDGES Associated Press Writer
© 2007 The Associated Press

WASHINGTON — The government of USA warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea.

The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year - the so-called background rate, the FDA said.